(62 days)
The Stat Profile pHOx Analyzer is intended for in vitro diagnostic use by health care professionals and for Point-of-Care users in the quantitative determination of pH, pCO2, pO2, sO2 %, Na+, K+, Cl-, iCa++, Glucose, Lactate, Hematocrit and Hemoglobin in whole blood. Whole blood pH, pCO2, and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
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§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.